Avelumab Injection
Avelumab injection is an immunotherapy used to treat metastatic Merkel cell carcinoma, urothelial carcinoma, and advanced renal cell carcinoma.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Avelumab Injection: Patient Information Guide
A plain-language walkthrough of Avelumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Avelumab injection (Bavencio) is an immunotherapy approved for several cancers in adult and select pediatric patients. Below are all supported uses:
- Bavencio treats metastatic Merkel cell carcinoma (MCC) — a rare, aggressive skin cancer — in adults and children 12 years and older
- Bavencio is used as maintenance treatment for locally advanced or metastatic urothelial carcinoma (bladder/urinary tract cancer) that has not gotten worse after first-line platinum-based chemotherapy
- Bavencio treats locally advanced or metastatic urothelial carcinoma that progressed during or after platinum-based chemotherapy
- Bavencio treats urothelial carcinoma that progressed within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy
- Bavencio, in combination with axitinib, is used as a first-line treatment for advanced renal cell carcinoma (kidney cancer)
⚙️How it works▾
Bavencio is a monoclonal antibody — a lab-made protein that targets a specific molecule in the body. It works by blocking a protein called PD-L1, which some tumors use to hide from the immune system. Normally, PD-L1 binds to receptors (PD-1 and B7.1) on immune cells, essentially telling them not to attack. By blocking this interaction, Bavencio releases the immune system's brakes and allows it to mount an anti-tumor response again. Bavencio has also been shown in lab studies to trigger a process called antibody-dependent cell-mediated cytotoxicity (ADCC), where immune cells are recruited to directly destroy cancer cells.
💊How it's taken▾
Bavencio is given as an intravenous (IV) infusion — delivered directly into a vein by a healthcare provider — over 60 minutes, once every 2 weeks. Treatment continues until the cancer progresses or side effects become unacceptable. No dose reductions are recommended for Bavencio itself; if a reaction occurs, the dose may be delayed or stopped entirely based on severity.
- For Merkel cell carcinoma and urothelial carcinoma: Bavencio is given alone every 2 weeks
- For advanced renal cell carcinoma: Bavencio is given every 2 weeks alongside axitinib, a separate oral medication taken twice daily (about 12 hours apart), with or without food
- Premedication with an antihistamine and acetaminophen is required before the first 4 infusions to reduce the risk of infusion reactions
🤒Side effects — in detail▾
The most commonly reported side effects with Bavencio include:
- Fatigue or weakness
- Musculoskeletal pain (muscle aches, joint pain, back pain)
- Infusion-related reactions (chills, fever, flushing, low blood pressure during or after infusion)
- Rash or skin changes
- Nausea
- Diarrhea or constipation
- Urinary tract infections
- Hypothyroidism (underactive thyroid)
- Decreased appetite
More serious immune-related reactions can affect the lungs, liver, colon, kidneys, skin, and hormone-producing glands. Contact your care team right away if you notice new or worsening symptoms in any of these areas — early action matters.
⚠️Warnings & precautions▾
- Immune-mediated reactions: Because Bavencio activates the immune system, it can cause it to attack healthy organs — including the lungs (pneumonitis), liver (hepatitis), colon (colitis), kidneys (nephritis), skin, and hormone glands. These can be severe or fatal and may occur during treatment or after it ends. Liver enzymes, kidney function, and thyroid levels should be monitored regularly.
- Infusion-related reactions: Reactions during or after the IV infusion can occur; premedication is given to lower this risk. Severe reactions may require slowing, stopping, or permanently discontinuing treatment.
- Transplant complications: Patients who receive or have received an allogeneic hematopoietic stem cell transplant (bone marrow transplant using donor cells) may face serious or fatal complications.
- Liver toxicity with axitinib: When Bavencio is used with axitinib for kidney cancer, the rate of serious liver enzyme elevations is higher than with Bavencio alone. More frequent liver monitoring is required in this combination.
- Heart risks with axitinib combination: Major cardiovascular events have been observed when Bavencio is combined with axitinib. Cardiovascular risk factors should be managed proactively, and treatment may need to be stopped for serious cardiac events.
- Embryo-fetal toxicity: Bavencio can harm an unborn baby. Effective contraception is required during treatment and for at least 1 month after the last dose.
🔀What it interacts with▾
Bavencio has limited documented drug interactions, but there are important clinical considerations:
- Axitinib: When Bavencio is combined with axitinib for kidney cancer, the risk of serious liver enzyme elevations is significantly higher — both drugs should be monitored closely and may need to be paused or stopped together if liver problems arise
- Corticosteroids and immunosuppressants: These are used to manage immune-related side effects caused by Bavencio; your care team will direct their use — do not start or stop them on your own
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Bavencio can cause fetal harm, including increased risk of miscarriage or stillbirth. Tell your doctor immediately if you become pregnant during treatment.
- Breastfeeding: Do not breastfeed during treatment or for at least 1 month after the last dose — potential harm to a nursing infant cannot be ruled out.
- Contraception: Females who can become pregnant should use effective birth control during treatment and for at least 1 month after the final dose.
- Children under 12: Safety and effectiveness have not been established in patients younger than 12 years of age.
- Children 12 and older: Bavencio is approved for metastatic MCC in patients 12 years and older with the same dosing as adults.
- Older adults (65+): No meaningful differences in safety or effectiveness compared to younger patients were observed across the MCC, UC, and RCC trials.
- Autoimmune disease or transplant history: Patients with active autoimmune conditions or prior stem cell transplants face higher risks — discuss your history with your oncologist before starting.
- Kidney or liver impairment: Mild to moderate impairment did not significantly affect how Bavencio behaves in the body; the effect of severe liver impairment is unknown.
📡Pharmacodynamics — effects in the body▾
The precise relationship between Bavencio exposure and its effects on the body — and how quickly those effects develop — has not been fully characterized. Because it works by modulating the immune system, the timing and degree of individual response can vary.
🔬Pharmacokinetics — how your body processes it▾
After IV administration, Bavencio reaches steady-state levels in the body after about 4 to 6 weeks of every-2-week dosing. Its half-life — the time it takes for the body to clear half the drug — is about 6 days on average, though this varies between patients. The drug is primarily broken down by a natural protein-degradation process (proteolytic degradation) rather than through the liver's usual drug-metabolizing enzymes. Factors such as age, sex, body weight, race, and mild to moderate kidney or liver impairment do not meaningfully change how the drug is processed.
📦How to store it▾
Store refrigerated at 36°F to 46°F (2°C to 8°C) in original package to protect from light. Do not freeze or shake the vial.
📄 Written from Avelumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Avelumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Bavencio supposed to do for my cancer? ▾
What should I expect when I go in for my infusion? ▾
What side effects are most likely, and which ones should make me call my doctor? ▾
Is it safe to take if I'm pregnant or trying to get pregnant? ▾
I've heard immunotherapy can cause the immune system to 'go haywire' — how worried should I be? ▾
My doctor wants to give me Bavencio with axitinib for kidney cancer — is that combination harder on the body? ▾
Is Avelumab Injection available over the counter? ▾
When was Avelumab Injection first available? ▾
💬 Answers drafted from Avelumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Avelumab Injection comes
Avelumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Bavencio is used intravenously to treat metastatic Merkel cell carcinoma in adults and children 12 years and older
- Bavencio is used intravenously as maintenance treatment for locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy
- Bavencio is used intravenously for previously treated locally advanced or metastatic urothelial carcinoma that progressed during or after platinum-based chemotherapy
- Bavencio is used intravenously in combination with axitinib as first-line treatment for advanced renal cell carcinoma
- Bavencio is administered as an intravenous infusion over 60 minutes, once every 2 weeks
- Bavencio requires premedication with an antihistamine and acetaminophen before each of the first 4 infusions; subsequent premedication is based on clinical judgment
- Bavencio should not be administered through the same IV line as other medications
- When used for renal cell carcinoma, Bavencio is given alongside axitinib taken orally twice daily — follow your prescriber's instructions for both medications
📊 Avelumab Injection across the U.S. market
How Avelumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Avelumab Injection is used
A general measure of how commonly Avelumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Avelumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Avelumab Injection prescribed? Of the 1,596 medications we measure, Avelumab Injection ranks #1,512 by Medicaid prescriptions — more than 5% of them.
Utilization by Avelumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
10 ML avelumab 20 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1875542
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Avelumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Avelumab Injection NDCs with Medicaid activity.
🔍 Compare Avelumab Injection products
A representative set of FDA-listed product records for Avelumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 20 mg/mL | Intravenous | EMD Serono, Inc. × 4 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Avelumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Avelumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Avelumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Avelumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1875534 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1875541In current FDA listingsClinical drug / strength (SCD) 10 ML avelumab 20 MG/MLRxCUI 1875542
Look up RxCUI 1875534 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Avelumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Avelumab Injection belongs to the Programmed Death Ligand-1 Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. EMD Serono, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.